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GxP Systems Lead / PM - Pharma

Ekman Associates, Inc.

Remote • Today

Easy Apply

Full-time

Depends on Experience

Security & Fire Lead Systems Specialist PM

Johnson Controls

Calumet City, Illinois • Today

Full-time

Compensation information provided in the description

Urgent Role || Lead GxP Validation Engineer @Fort Worth, TX || Contract (All Visa)

Vaiticka Solution LLC

Fort Worth, Texas • 7d ago

Easy Apply

Contract, Third Party

$55 - $60

Pharma IT Testing & Validation Delivery Lead

Katalyst Healthcares and Lifesciences

Boston, Massachusetts • Today

Full-time

IT Lead, Product Analyst, Third Party Management (TPM)

Johnson & Johnson

New Brunswick, New Jersey • Today

Full-time

USD 94,000.00 - 151,800.00 per year

Platform Engineering Lead, VP

State Street Corporation

Quincy, Massachusetts • Today

Full-time

USD 120,000.00 - 217,500.00 per year

Job Details

Skills

GXP SYSTEMS
VEEVA VAULT
ETMF
CTMS)ITSM
COMPUTER SYSTEM VALIDATION
GCP

Summary

Title: GxP Systems Lead / PM - Pharma
Location: Remote

Ekman Associates is a management consulting firm that specializes in developing business, digital, and technology strategy, delivering solutions, and addressing human resource demands.

Summary:
We are currently seeking a GxP Systems Lead SME who is experienced, but equally important, very hands-on, execution-focused, and able to work with a strong sense of urgency.

While this is a senior/experienced role, we are not looking for someone who provides primarily advisory or strategic input. We expect this resource to take ownership, actively produce deliverables, drive work forward, and build alignment across stakeholders with minimal oversight.

Key Skills

Expertise in managing a portfolio of GxP systems, including Veeva Vault (RIM and Clinical modules such as eTMF and CTMS)ITSM tools (SNOW)
Strong expertise in Computer System Validation (CSV)
Must have Google Cloud Platform (Good Clinical Practice) and R&D expertise

Responsibilities:

Proven hands-on experience supporting a portfolio of GxP systems, including Veeva Vault (RIM and Clinical modules such as eTMF and CTMS), as well as non-Veeva systems/platforms (e.g., Egnyte, DOT Compliance, etc.) in regulated environments.
Strong expertise in Computer System Validation (CSV), including risk-based validation and end-to-end ownership of validation lifecycle deliverables (URS, FS, IQ/OQ/PQ, TM, etc.) from initiation through closure.
Strong knowledge of global GxP regulations (FDA, EMA, ICH), GAMP 5, and their practical application to IT systems, with a focus on maintaining audit and inspection readiness.
Demonstrated project management experience, including planning, execution, risk management, and delivery of system implementations and enhancements.
Ability to effectively collaborate with cross-functional stakeholders across Quality, Clinical, Regulatory, and IT to gather requirements, drive decisions, and deliver compliant solutions.
Experience managing system configurations, releases, integrations, and enhancements across both Veeva and non-Veeva systems, including change controls and impact assessments.
Strong understanding of data integrity principles (ALCOA+), system governance, SOP development, and vendor management for GxP applications.
Experience performing gap assessments against current SOPs and regulatory requirements and executing the subsequent remediation work would be a plus.

Qualifications:

A Bachelor's degree (or equivalent work experience) in IT, Engineering, or related science and math discipline with a Technology emphasis.
Expertise in managing a portfolio of GxP systems, including Veeva Vault (RIM and Clinical modules such as eTMF and CTMS)ITSM tools (SNOW)
Strong expertise in Computer System Validation (CSV)
Strong knowledge of global GxP regulations (FDA, EMA, ICH), GAMP 5, and their practical application to IT systems.
Ability to understand complex business needs and adapt appropriately.
Ability to collaborate with senior-level management.
Ability to lead/influence others effectively.
Strong & Effective communication and presentation skills.

Qualified Candidates Only : If you wish to learn more about this opportunity and additional qualifications/responsibilities, please submit your resume . To learn more about Ekman Associates, Inc. please visit our website at

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91010724
Position Id: 26-00029
Posted 2 hours ago

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Remote

•

Today

Job Role: Business Analyst with Project Management (BA/PM) Location: Cambridge MA - Remote Mode: Long Term Project Job Required: We need emphasize on Gxp, CRO, Biotech, change requests, requirement traceability matirx, decommisioning applications, small projects , vendor management and stake holder management.10+ years of combined experience in Life Sciences IT, including:Minimum 5 years in a GxP-regulated system administrator or support capacity.Minimum 5 years in project management, delivering

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Contract

Depends on Experience

Validation Lead-Remote

Remote or Raritan, New Jersey

•

Today

Role: Validation Lead Location: Raritan, NJ(Hybrid) Duration: 6+ Months Job Description: Job Details: 5+ years of Computer System Validation (CSV) experience in GxP-regulated environments, with hands-on experience in retro-validation activities and 21 CFR remediation projects with knowledge of CSA, GAMP 5, 21 CFR Part 11, Annex 11, and audit/inspection readiness. Experience in the Pharmaceutical, biotechnology, or medical device industry Experience in FDA and/or Global regulated environment

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Contract

Computer Systems Validation Engineer

Remote

•

Today

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Director, Global Digital & Technology Systems

Remote

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Full-time

USD 172,500.00 - 232,500.00 per year